Late Clinical Events Associated With COVID-19 Infection
NCT ID: NCT04591613
Last Updated: 2022-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
1000 participants
INTERVENTIONAL
2020-12-31
2025-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.
Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outcomes in Hospitalized Older Patients With COVID-19
NCT04385212
Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT)
NCT04597736
National Survey of Symptoms of People Aged 70 and Overs Diagnosed With COVID-19
NCT04343781
Follow-up of Respiratory Sequelae of Hospitalized Patients With COVID-19
NCT04505631
PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs
NCT04459351
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed. In parallel, the prevalence of the main symptoms observed more than 3 weeks after the onset of a COVID-19 will be estimated through partnerships with existing cohort studies in the general population or in the population followed for COVID-19, still symptomatic or not at 3 weeks of infection.
Longitudinal implementation of bio-libraries will allow this cohort to also constitute a bridge between clinicians and researchers.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standardized clinical and paraclinical follow-up
Standardized clinical and paraclinical follow-up will be offered in one of the referring investigator centers. Patients will be able to benefit from additional biological samples. Questionnaires will be completed by the patient or with the help of clinical research staff in paper format.
All patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID.
Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.
Total serum, plasma and naso-paaryngeal samples will be collected.
Questionnaire
Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.
Biocollection
Total serum, plasma samples will be collected
Follow-up visit
All patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Questionnaire
Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.
Biocollection
Total serum, plasma samples will be collected
Follow-up visit
All patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
o Positive RT-PCR SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
o Associated with at least one event : x Anosmia occurring after February 2020 x OR COVID 19 evocative scanner x OR ≥ 2 contemporary symptoms of the virological sample from: asthenia, cough, dyspnea, fever, myalgia, dysgeusia, diarrhea AND not present prior to diagnosis
* AND persistence of at least one symptom present in the first 3 weeks of a COVID-19, more than 8 weeks away from the first symptoms of COVID-19. OR late onset of at least one new symptom a minimum of 3 weeks and a maximum of 6 months after the first symptoms of a CoV-2 SARS infection.
* First symptoms less than 6 months old on the day of inclusion
* To benefit from a State Health Insurance or Medical Aid plan
* Have signed an informed consent for inclusion.
Exclusion Criteria
* Patient under protection of justice
* Patient who required intensive care management :
* more than 5 days
* OR requiring orotracheal intubation
* OR having required high flow ventilation (optiflow)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tourcoing Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Olivier ROBINEAU, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CH TOURCOING
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ch Auxerre
Auxerre, , France
CHU Caen
Caen, , France
CHRU Lille
Lille, , France
CH Melun Marc Jacquet
Melun, , France
CH Sud Seine et Marne
Nemours, , France
AP-HP Hôpital Hôtel-Dieu
Paris, , France
CHU de Saint-Etienne
Saint-Priest-en-Jarez, , France
CH Tourcoing
Tourcoing, , France
CHRU Tours
Tours, , France
CHRU Nancy
Vandœuvre-lès-Nancy, , France
Centre Hospitalier Bretagne Atlantique
Vannes, , France
CH André Rosemon de Cayenne
Cayenne, , French Guiana
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RIPH_2020_09
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.